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Patients feel FDA is disingenuous about interest in LASIK complications

5/4/2008

LASIK is a 2.5 billion dollar per year industry. LASIK is considered by some as the “gravy train” of ophthalmology. Recently many questions have been raised about the frequency and severity of complications, and now many are wondering if LASIK really lives up to the hype.

In the past decade, several lasers have received FDA approval for use in LASIK surgery. A report of data from FDA clinical trials for LASIK, including current technology, reveals that approximately 20% of patients report complications.1 The report shows that six months after LASIK, 17.5 percent of patients reported halos, 19.7 percent reported glare, 19.3 percent had night-driving problems and 21 percent complained of dry eyes. It appears that if FDA had properly classified these “symptoms” as adverse events or complications, the devices would have failed to meet safety requirements for approval.

The FDA’s MedWatch program allows healthcare professionals and consumers to report adverse events associated with medical devices, such as those used to perform LASIK. However, patients are not informed about the MedWatch program and there is no enforcement of reporting by physicians. The inconsistency between the reported complication rates from LASIK clinical trials and the number of adverse events reported to the FDA through the MedWatch program clearly shows that complications from LASIK are grossly underreported.

Reports of widespread, serious problems with LASIK prompted FDA to hold a post-market meeting on April 25, 2008 to hear patient complaints and to accept recommendations from a panel of experts. The panel was chaired by LASIK surgeon, Dr. Jane Weiss. In her closing remarks, Dr. Weiss blamed the problems on “some surgeons who should be doing a better job”, rather the surgery itself. Patients felt the hearing was a sham.

Two weeks before the FDA hearing, the American Society of Cataract and Refractive Surgery (ASCRS), a 10,000 member strong organization of ophthalmic surgeons, issued a press release stating the organization had formed a joint task force with FDA, National Eye Institute (NEI), and the American Academy of Ophthalmology (AAO) to conduct a prospective post-LASIK quality of life study. The timing of the press release seems to indicate that the LASIK industry had inside information that the FDA had no plans to act swiftly on recommendations from the public at the hearing. The unprecedented partnership between the LASIK industry and the FDA has raised eyebrows in the patient community.

These events followed on the heels of media reports of patients who experienced depression, and a report of suicide, due to complications from LASIK. ASCRS fired back (see below) at the North Carolina newspaper that broke the story in February. A flurry of bad press for the LASIK industry followed. By early March, the LASIK industry had launched its damage control campaign by releasing preliminary findings from a meta-analysis of LASIK studies, which showed a 95% satisfaction rate. Patients consider this meta-analysis a smokescreen to conceal the high rate of complications, such as dry eyes and night vision impairment. Four suicides and numerous cases of depression related to LASIK were reported at the FDA hearing.

LASIK industry leadership subsequently announced the names of doctors who were hand-picked to design and conduct the post-LASIK quality of life study with the task force. One of the doctors selected for the study is a well-known defense expert witness who testifies against LASIK patients who file medical malpractice lawsuits, has financial ties to the LASIK industry, and has made public statements that LASIK complications do not lead to depression. Patients believe that all of the doctors chosen for the study are biased and lack objectivity, and that the study as proposed amounts to “the fox guarding the hen house”.

In a National Public Radio interview this week, , an FDA spokesperson, encouraged patients to report LASIK complications to the Agency using the MedWatch program. Weick-Brady stated that halos, starbursts, and problems with night vision are considered adverse events.

The question that many damaged LASIK patients now want the FDA to answer is, how did a medical device with a 20% rate of adverse events receive FDA approval in the first place?

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“There is simply no scientific basis to support a direct connection between a sub-optimal outcome from eye surgery and suicide.”
Lindstrom, Richard. (2008, March 12) Letter to the News & Observer
Originally published at http://www.newsobserver.com/opinion/letters/story/996053.html